Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of fid 119515a

Conditions: Dry Eye

Summary: the purpose of this study was to compare the effect of fid 119515a to blink® tears on the integrity of tear film in adults with a history of dry eye in both eyes.

subjects who met the enrollment criteria were randomized in a 2:1 manner to receive treatment with fid 119515a or blink® tears respectively for this 1-day, single-dose study.

Eligibility criteria:
inclusion criteria: * sign informed consent. * best corrected visual acuity (bcva) of 55 or greater in each eye as measured by an etdrs chart (letters read method). * at least a 3 month documented history of dry eye in both eyes. * tbut and ocular surface disease index (osdi) questionnaire score as specified in protocol. * other protocol-defined inclusion criteria may apply. exclusion criteria: * pregnant or breastfeeding. * any evidence of ocular infection or inflammation within 30 days prior to screening. * any ocular surgery. * ocular trauma requiring medical or pharmacological treatment within 1 year of screening. * current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy. * use of topical ocular prescription or non-prescription medications within 30 days of screening. * participation in any other clinical trial within 30 days prior to screening. * other protocol-defined exclusion criteria may apply.

Keywords: dry eye tear film tear break-up time ocular surface eye drops
flexitouch® home maintenance therapy or standard home maintenance therapy in treating patients with lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or endometrial cancer

Conditions: Lymphedema; Stage 0 Cervical Cancer; Stage 0 Uterine Corpus Cancer; Stage 0 Vulvar Cancer; Stage I Uterine Corpus Cancer; Stage I Vulvar Cancer; Stage IA Cervical Cancer; Stage IB Cervical Cancer; Stage II Uterine Corpus Cancer; Stage II Vulvar Cancer; Stage IIA Cervical Cancer; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage III Uterine Corpus Cancer; Stage III Vulvar Cancer; Stage IV Uterine Corpus Cancer; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer; Stage IVB Vulvar Cancer

Summary: this randomized phase iii trial is studying flexitouch® home maintenance therapy to see how well it works compared with standard home maintenance therapy in treating patients with lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or endometrial cancer. flexitouch® home maintenance therapy may lessen lower-extremity lymphedema caused by treatment for gynecologic cancer. it is not yet known whether the flexitouch® system is more effective than standard home maintenance therapy in treating lymphedema.

primary objective: i. compare the effectiveness of the flexitouch® system to standard home lymphedema therapy (manual lymphatic drainage) in the management of lower-extremity lymphedema in women with a history of cervical, vulvar, or endometrial cancer. secondary objective: i. compare the quality of life (qol) and functional status between patients using the flexitouch® system and those following standard home lymphedema treatment (manual lymphatic drainage) programs in the management of lower-extremity lymphedema outline: this is a multicenter study. patients are stratified according to site of cancer (cervical vs vulvar vs endometrial) and stage of lymphedema at diagnosis. patients are randomized to 1 of 2 treatment arms. arm i: patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. arm ii: patients receive flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks. clinical staff measure patients' lower limb (both) volumes and patients complete quality of life questionnaires at baseline, every 8 weeks during treatment, and at completion of study treatment.

Eligibility criteria:
criteria: * has lower-extremity lymphedema on one side of the body caused by surgery, chemotherapy, and/or radiation therapy. * at least 6 months since clinic therapy for lower-extremity lymphedema * is within 3 years from finishing cancer treatment * no active or recurrent cancer * more than 3 months since cancer treatment
concordance and acceptability of self-screening versus screening by a healthcare professional for hpv, a risk factor for anal cancer, by swab in people living with hiv

Conditions: HPV Infection

Summary: anal canal cancers are on the increase in france, with around 2,000 new cases per year. these lesions can be detected by directed biopsies or smear tests. the incidence rate of anal cancer is 30 times higher in people living with hiv than in the general population. according to a recent study, the risk of anal cancer is highest in this population, but is also high in heterosexual men over 30 and women over 30. however, the proposal of a proctological examination in this population is not systematic. in france, there is no hpv screening for people living with hiv, but there is a recommendation for proctology consultation in certain cases, notably for men who have sex with men (msm) or for women with vaginal cervical lesions. several oncogenic hpv serotypes have been identified in the genesis of anal cancer. the serotype identified as the most carcinogenic is hpv-16 (89%). this study will look at anal hpv screening in people over 30 living with hiv, thus including a population for which no screening is currently offered (heterosexual men living with hiv and women living with hiv without vaginal cervical lesions), and will assess the concordance and acceptability of self-screening versus screening by a healthcare professional as part of a comprehensive anal cancer screening strategy in this population.


Eligibility criteria:
inclusion criteria: patient : * living with hiv * aged 30 or over * resident on reunion island and followed at the university hospital of reunion island (the only follow-up center on the island) * able to perform anal self-sampling * able to answer a questionnaire * affiliated with or benefiting from a social security scheme * have given free, informed and signed consent exclusion criteria: * people with a previous anal swab less than 7 days old * persons with a known current diagnosis of anal cancer * persons deprived of liberty by judicial or administrative decision, minors, and persons under legal protection: guardianship or curators

Keywords: hpv hiv anal screening
community-based accompaniment with supervised antiretrovirals in lima, peru

Conditions: HIV; AIDS; HIV Infections

Summary: using quantitative and qualitative data, this study will assess the impact of community accompaniment with supervised antiretrovirals (casa) on hiv-positive individuals and community members in lima, peru.

community-based accompaniment with directly observed antiretroviral therapy (dot-haart) may improve adherence and clinical outcomes among impoverished individuals starting haart in resource-poor settings. furthermore, the utilization of community health workers may build social capital. this is cluster-randomized trial, with randomization at the level of health centers. individuals in both intervention and control clusters will receive community-based adherence support (monthly adherence visits) and standard care. in addition, individuals residing in intervention clusters will receive 12 months of community-based dot-haart. we will enroll patients as well as community members (health providers, treatment supporters, and community health workers) to assess individual and community-level outcomes.

Eligibility criteria:
inclusion criteria for patient cohort: * age greater than or equal to 18; * diagnosis if hiv and meeting criteria for haart; * lives in poverty; * either: 1) haart naïve or 2) starting salvage therapy due to virologic failure; * documentation of baseline cd4 cell count and hiv load; * residence and receipt of hiv healthcare within the study catchment area exclusion criteria for patient cohort: - imprisoned or cannot give informed consent. inclusion criteria for community cohort: * working in a health establishments in study region; * if health personnel, contracted employee caring for people living with hiv/aids. exclusion criteria for community cohort: - cannot give informed consent

Keywords: peru dot hiv aids community based social capital
a study of oraxol® in gastric cancer patients

Conditions: Advanced Metastatic Gastric Cancer; Recurrent Gastric Cancer

Summary: the main objectives of this study are to determine the maximum tolerated dose (mtd) and recommend dose (rd) of oraxol® in phase i and to determine the objective response rate of oraxol® in phase ii.

administration schedule: 1 cycle of oraxol® is 28 days and oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).

Eligibility criteria:
inclusion criteria: 1. patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phasei) 2. advanced/metastatic/recurred gastric cancer(phaseii) 3. ecog performance status ≤ 2 4. patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: wbc≥4000/mm3; platelet ≥100,000/mm3; hemoglobin≥9.0g/dl; anc≥ 1,500 /mm3; creatinine ≤ 1.5mg/dl; ast/alt/alp ≤ 3 x the upper limit of normal; total bilirubin ≤2.0mg/dl \*ast/alt/alp ≤ 3 x the upper limit of normal but \<5 if liver or bone metastasis is present exclusion criteria: 1. patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to cns or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection) 2. patients who have received bone marrow transplant or are to receive bone marrow transplant. 3. patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months.

Keywords: oraxol® oral paclitaxel paclitaxel hm30181a mtd dlt rd
psychoeducational approach to improve health in lupus

Conditions: Systemic Lupus Erythematosus

Summary: we will study the relationships among patient/partner communication, social support, and self-efficacy (a person's belief in the ability to manage his or her disease) as they affect the health of people with systemic lupus erythematosus (sle, or lupus) over time. we are assigning 150 people with lupus and their partners to either (1) receive counseling to improve self-efficacy, partner support, and patient/partner problem solving or (2) see an informational film about lupus. we will follow study participants for 12 months to find out about their physical and mental health, disease activity, beliefs that they can take steps that help them feel better, coping, social support, and couples communication.

studies have shown that patient self-efficacy in disease management and social support predict physical and mental health and disease activity in lupus. we wished to study the relationships among patient/partner communication, social support, and self-efficacy as they influence patient health longitudinally. we are randomizing 150 lupus patients and their partners to either (1) participate in a counseling intervention to improve self-efficacy, partner support, and patient/partner problem-solving in lupus management or (2) see an informational film about lupus (control). the counseling intervention includes an initial in-person session followed by five monthly telephone calls to monitor and reinforce problem-solving. we will follow patients for 12 months for self-reported physical and mental health, disease activity, self-efficacy, coping, social support, and couples communication.

Eligibility criteria:
inclusion criteria: * has partner willing to participate in study exclusion criteria: * unable to read and write english questionnaires * unable to be reached by phone * rheumatologist considers patient unable to participate, generally due to patient cognitive problems or severe illness

Keywords: sle lupus educational intervention health education social support network outcomes research self-help
safety and efficacy of everolimus (afinitor®) in chinese adult patients with angiomyolipoma associated with tuberous sclerosis complex.

Conditions: Renal Angiomyolipoma

Summary: the purpose of this study was to assess the safety and efficacy of everolimus (afinitor®) in chinese patients with renal angiomyolipoma (aml) associated with tuberous sclerosis complex (tsc).

this was an open label, single arm, multi-center, phase iv post-approval commitment (pac) study with once daily oral dose of 10 mg everolimus in participants with renal aml associated with tsc. there were three separate phases in this study: a screening phase, an open-label treatment phase where participants received everolimus for 48 weeks or until disease progression, and a treatment discontinuation follow-up phase for patients who discontinue study drug for reasons other than disease progression. every participant had an end of treatment visit within 28 days after last dose and a safety follow-up visit 30 days after last dose.

Eligibility criteria:
inclusion criteria: * eligible for treatment with everolimus as per the locally approved label. * presence of at least one aml ≥ 3 cm in its longest diameter using ct or mri. exclusion criteria: * aml related bleeding or embolization during the 6 months prior to enrollment. * history of myocardial infarction, angina or stroke related to atherosclerosis. * impaired lung function. * significant hematological or hepatic abnormality. * any severe and/or uncontrolled medical conditions.

Keywords: tsc tuberous sclerosis complex aml afinitor everolimus rad001 mtor kidney lymphangioleiomyomatosis renal angiomyolipoma
system accuracy of the blood glucose monitor for personal use jt100

Conditions: Diabetes Mellitus

Summary: this study assesses the system accuracy a blood glucose monitoring systems pursuant to iso 15197

this study assesses the system accuracy the blood glucose monitoring systems for personal use tj100 pursuant to iso 15197:2015 guidelines

Eligibility criteria:
inclusion criteria: * male or female patients with clinical indication for blood glucose testing * signed form of consent * minimum age of 18 years * subjects are legally competent and capable to understand character, meaning and consequences of the study exclusion criteria: * pregnancy or lactation * severe acute disease (at study physician's discretion) * acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion) * current constitution that does not allow participating in the study (e.g. hematocrit out of * the devices's specifications, medication known to influence blood glucose measurements; appendix a of iso 15197) * being unable to give informed consent * age younger than 18 years * legally incompetent
eye exercise, transcutaneous electrical nerve stimulation on prevention of myopia progression

Conditions: Myopia

Summary: in taiwan, the increasing prevalence of myopia shows a decline with age. myopia has become a serious ocular problem in children because high myopia may lead to retinal damage, cataract and glaucoma. a prevention of myopia progression (pmp) will be developed and examined. this promotion program includes strategies such as a frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on the prevention of myopia progression. eye exercise defined as a computerized image led motion. the study aims to examine the effect of the implementation on the pmp.

this is an experimental study. a sample size of 25\~40 participants from an elementary school will be recruited in the randomized controlled study.the sequential arrangement is arranged in a random manner for the participating children. a investigation of four groups will be designed for the pmp: group 1 (frequency following response, group 2(frequency following response,and eye exercise), group 3 (frequency following response, eye exercise, transcutaneous electrical nerve stimulation and stimulating auricular acupoints), and group 4, the control group. the pmp implement a 30 minute intervention two times per the investigators. pre-test and post-test (eyeball diopter detection and sellen's vision chart) will be carried out. the duration of each intervention is provided for two days. the washout period following next intervention is 7 days at least. after completing four intervention, the effect of the best intervention of eight the investigator will be conducted.the evaluation time of the interventions will be observed at first-time and one-month observations. a descriptive and inferential statistics by spss will be used for data analysis. the investigators will apply the frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on pmp among taiwan schoolchildren. the findings of the study may provide information for promotion of visual health for schoolchildren and their parents.

Eligibility criteria:
inclusion criteria: * myopia is defined as the equivalent spherical surface degree of any one is less than or equal to -0.50d * do not use cyclogel or atropine * at least the eye ointment is deactivated for at least seven days * no plastic tablets are currently used * at least the plastic tablets are not allowed to be retired for more than seven days exclusion criteria: * children with current traumatic and unrecoverable other eye disease
screening for urinary incontinence by primary care providers

Conditions: Urinary Incontinence

Summary: the purpose of this study is to: * assess the rate of screening for urinary incontinence (ui) in women by their primary care providers * identify the type of screening used by primary care providers * identify barriers to screening for ui * identify differences in screening rates between specialties * assess whether primary care providers view ui as a serious medical problem * assess the comfort level of primary care providers in the diagnosis and treatment of ui * identify primary care providers' preferred mode of learning more about ui

ui is a very common condition whose prevalence can be expected to increase dramatically in the coming decades. treatment options are available to improve women's health and quality of life. however, inadequate communication between physicians and patients leads to decreased diagnosis and treatment. past studies evaluating the use of screening by primary care providers, who act as gatekeepers in our healthcare system, clearly demonstrate that improvements must be made in the screening system. we propose a survey of local primary care providers to quantify screening rates for ui and identify barriers to successful screening. the information collected in this survey will allow us to identify methods such as targeted education opportunities and patient literature or questionnaires that will assist providers and their patients in initiating discussion and evaluation of ui.

Eligibility criteria:
inclusion criteria: * all primary care providers in the greater rochester metropolitan area, including: primary care medical doctors (md), doctors of osteopathy (do), primary care nurse practitioners (np), and physician assistants (pa) exclusion criteria: * physicians in the greater rochester metropolitan area who are not primary care providers
using question prompt lists during pediatric asthma visits to increase adolescent involvement

Conditions: Asthma

Summary: the purpose of this study is to conduct a randomized controlled trial with english and spanish-speaking adolescents to compare the effectiveness of an adolescent "asthma question prompt list" with a supportive educational video intervention with usual care. the hypothesis of this study is that by showing the parents and adolescents the educational video and then providing the adolescents with the one-page "asthma question prompt lists" to use during their visits will improve: (a) asthma control, (b) adolescent self-efficacy in managing asthma, and (c) adolescent quality-of-life.

the study uses a randomized controlled trial design stratified by provider to assess the impact of an adolescent "asthma question prompt list" combined with a supportive educational video emphasizing the importance of adolescent involvement and question-asking on communication during pediatric visits. this application is based on social cognitive theory. self-confidence or self-efficacy is a central component of social cognitive theory (sct) application of social cognitive theory (sct) in asthma populations has shown that technical advice from providers is one external factor that can improve asthma management self-efficacy. additionally, personal beliefs, such as outcome expectations, and family factors, such as parent and adolescent responsibility for asthma self-management, have been shown to affect adolescent self-efficacy and disease management outcomes. prior work has found that adolescent self-efficacy in asthma management correlates strongly with health status, adherence, asthma medication device technique, asthma symptoms, and impact of illness on the family. all adolescents will have their medical visits audio recorded. the adolescent will be interviewed after his/her medical visit while his/her caregiver/parent completes a survey at the time of study enrollment. this same procedure will be used when the adolescent and caregiver/parents return for the 6- and 12-month follow-up visits.

Eligibility criteria:
inclusion criteria: * ages 11 to 17 years; * speak and read english or spanish; * have persistent asthma; * are present for an acute or follow-up asthma visit or a well-child visit; * and have previously visited the clinic at least once for asthma. adolescents' parents will be eligible if they are at least 18 years of age, speak and read english or spanish, and are the legal guardian of the adolescent. exclusion criteria: * present for gastrointestinal complaints or other non-asthma related acute illness.

Keywords: communication provider caregiver adolescent
pediatric fiberglass crown in primary teeth

Conditions: Dental Caries; Dental Plaque

Summary: this randomized controlled clinical trial aims to evaluate the clinical success of fiberglass crowns applied to primary teeth and to assess the impact of two different luting cements on the success of the fiberglass crowns. the main questions to answer are: * will fiberglass crowns demonstrate sufficient clinical success to serve as a viable alternative to existing pediatric crowns? * will there be any differences in the clinical success and mechanical properties of fiberglass crowns based on the type of luting cement used? thirty-eight children (60 teeth), between 5 and 9 years old (7.03±1.14), enrolled for the study. the researchers evaluated the clinical success of fiberglass crowns bonded with two different types of luting cement (1: fujione; 2: fujicem 2) based on retention, anatomical integrity, effect on periodontal health and parental satisfaction. participants will: -visit the clinic 1st, 3rd, 6th, 12th months after cementatiton.


Eligibility criteria:
inclusion criteria: for participants: * absence of any systemic disease * absence of any periodontal disease * no unilateral chewing habit * a frankl scale score of three-four for teeth: * no percussion or palpation sensitivity * no malocclusion * no pathological mobility * no pulpal treatment due to caries or other reasons * had sound cervical margins * not hypoplastic or hypocalcified * had opposing functioning teeth * had physiological root resorption not exceeding one-third of the root length * had deep dentin caries with two or more surface that do not contain pulp involvement exclusion criteria: * did not attend their follow-up appointments

Keywords: fiberglass crown glass-ionomer cement resin-modified glass-ionomer cement primary molar teeth